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Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
Sponsor: Basking Biosciences, Inc.
Summary
The purpose of this study is to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset. Participants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. A total of 228 patients are planned in this study.
Official title: A Multicenter, Double-blinded, Placebo-controlled, Single Ascending Dose, Two-part, Randomized, Phase 2 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BB-031 in Acute Ischemic Stroke Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
228
Start Date
2024-07-31
Completion Date
2027-09
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
BB-031
Solution for injection
Placebo
0.9% sodium chloride for injection
Locations (24)
HonorHealth Bob Bove Neuroscience Institute
Scottsdale, Arizona, United States
Mills Peninsula Medical Center
Burlingame, California, United States
MemorialCare Long Beach Medical Center
Long Beach, California, United States
California Pacific Medical Center
San Francisco, California, United States
Pacific Neurosciences Institute at Saint John's Physician Partners
Torrance, California, United States
Baptist Health Medical Center
Jacksonville, Florida, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
WakeMed
Raleigh, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, United States
Valley Baptist Medical Center - Harlingen
Harlingen, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada